Myotonometer Intra- and Inter Examiner Reliability on Spinal Muscular Atrophy

Quantification of the Postural Muscles Mechanical Properties of Individuals With Spinal Muscular Atrophy Using Myotonometer: Intra- and Inter Examiner Reliability

The primary aim of the study was to measure the intra-rater and inter-rater reliability of MyotonPRO in measuring postural muscle tone and mechanical properties in individuals with spinal muscular atrophy (SMA). The secondary aim is to question the existence of a relationship between the functional levels of individuals with SMA and their muscle tone and biomechanical properties. It is assumed that the outputs to be obtained from this research will form the norm data for moyotonometer evaluation in children with SMA.

Study Overview

• Status: Enrolling by invitation
• Conditions: Spinal Muscular Atrophy; Muscle Tone Poor
• Intervention / Treatment: Diagnostic test: MyotonPRO

Detailed Description

It seems to be important to examine peripheral changes in the pathogenesis of SMA. Although it shows that the target center in SMA is alpha motor neurons located in the anterior horn of the spinal cord, considering the interaction network of interneurons, cerebellum, neuromuscular junction, gamma-alpha motor neuron pool, descending and ascending pathways, and reflex arc, it has potential to be investigated in individuals with SMA. This suggests that it may have important consequences for peripheral mechanisms. It may be important to examine muscle mechanical properties to reveal any potential correlations between SMA types and disease progression. In addition, moyotonometer results can be a key evaluation method in examining treatment efficacy, diagnosis and disease course. However, in order for these activities to be observed with myotonometer, first of all, the reliability of its use in individuals with SMA should be questioned.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34810
    • Seval Kutlutürk Yıkılmaz
  • Kavacık
    • Istanbul, Kavacık, Turkey, 34810
      • Seval Kutlutürk Yıkılmaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study was to be conducted with children with a diagnosis of Spinal Muscular Atrophy (SMA) followed in the Pediatric Chest Diseases Outpatient Clinic at Bağcılar Medipol Mega University Hospital and Istanbul Medipol Hospital, and with their families meeting the inclusion criteria of the study.

Description

Inclusion Criteria:

• Between 0-4 years old
• Diagnosed with spinal muscular atrophy (SMA)
• Children who continue their medical treatment at home and are not in intensive care
• Children of families who agreed to participate in the study and approved the informed consent form.

Exclusion Criteria:

• Children of families who disagreed to participate in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with Spinal Muscular Atrophy; The patients were included if they were between 0 to 4 yeats, with a diagnosis of Spinal Muscular Atrophy.	Diagnostic test: MyotonPRO; Evaluation of biomechanics and viscoelastic properties of posture muscle in children with Spinal Muscular Atrophy. The biomechanical and viscoelastic properties of the posture muscle in children with Spinal Muscular Atrophy. will be measured with the MyotonPRO device.
Healthy children; The healthy age-matched control group was included.	Diagnostic test: MyotonPRO; Evaluation of biomechanics and viscoelastic properties of posture muscle in children with Spinal Muscular Atrophy. The biomechanical and viscoelastic properties of the posture muscle in children with Spinal Muscular Atrophy. will be measured with the MyotonPRO device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomechanical and Viscoelastic Properties	The biomechanical and viscoelastic properties of the plantar fascia will be measured with MyotonPRO device. The MyotonPRO (Tallin, Estonia) is a portable hand-held myotonometer. This device is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by different parameters such as tone, elasticity, and stiffness. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.	Day 1.

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: Seval Kutlutürk Yıkılmaz, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): October 15, 2022

Study Registration Dates

• First Submitted: August 27, 2022
• First Submitted That Met QC Criteria: August 27, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Cord Diseases; Motor Neuron Disease; Muscular Atrophy; Atrophy; Muscular Atrophy, Spinal; Muscle Hypotonia
• Other Study ID Numbers: E-10840098-772.02-3771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No